In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials

Nat Commun. 2021 Jun 23;12(1):3861. doi: 10.1038/s41467-021-23998-w.

Abstract

The cost of clinical trials is ever-increasing. In-silico trials rely on virtual populations and interventions simulated using patient-specific models and may offer a solution to lower these costs. We present the flow diverter performance assessment (FD-PASS) in-silico trial, which models the treatment of intracranial aneurysms in 164 virtual patients with 82 distinct anatomies with a flow-diverting stent, using computational fluid dynamics to quantify post-treatment flow reduction. The predicted FD-PASS flow-diversion success rates replicate the values previously reported in three clinical trials. The in-silico approach allows broader investigation of factors associated with insufficient flow reduction than feasible in a conventional trial. Our findings demonstrate that in-silico trials of endovascular medical devices can: (i) replicate findings of conventional clinical trials, and (ii) perform virtual experiments and sub-group analyses that are difficult or impossible in conventional trials to discover new insights on treatment failure, e.g. in the presence of side-branches or hypertension.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Algorithms
  • Clinical Trials as Topic / methods
  • Computer Simulation*
  • Female
  • Humans
  • Hydrodynamics*
  • Intracranial Aneurysm / physiopathology
  • Intracranial Aneurysm / therapy*
  • Male
  • Middle Aged
  • Models, Theoretical
  • Reproducibility of Results
  • Stents*
  • Treatment Outcome